Jean M. Hoffman
Senior Editor

In February, Toys“R”Us Inc. joined the ranks of Sears Holdings (Sears and Kmart), Wal-Mart, and Target when it announced a new policy: It will systematically phase out products containing polyvinyl chloride (PVC or vinyl). The toy retailer was responding to consumers concerned about numerous toy recalls last year and an aggressive anti-PVC campaign spearheaded by the Center for Health, Environment, and Justice (CHEJ).

Toys“R”Us has told all its manufacturers that products they ship after March 1 must comply with strict new standards. These include morefrequent third-party testing of toy samples, date coding of all products, a more-stringent standard of 90 ppm for lead in surface coatings (the federal standard is 600 ppm), the elimination of nickel-cadmium batteries, as well the reduction of PVC use. By the end of 2008, juvenile products sold in any Toys“R”Us or Babies“R”Us store in the U.S. must be produced without the addition of phthalates (a group of plasticizers that make vinyl toys soft, flexible, and durable). In addition, Toys“R”Us says future efforts will focus on giving customers toys that are PVC-free.

Concerns over PVC use in toys and children’s articles, particularly those intended for the mouth, were first raised in a petition from an activist group to the Consumer Products Safety Commission (CPSC) in 1998. The standards for toys are set by the CPSC. The Phthalate Esters Panel of the American Chemistry Council (ACC) says concerns were based on negative health effects seen in rats and mice fed high doses of the phthalate DEHP over extended periods. “To be ultraconservative,” it says, “the CPSC suggested that manufacturers stop using phthalates in soft rattles and teething rings, i.e., articles intended for the mouth.” American manufacturers complied. The Toy Industry Association (TIA) also agreed and later incorporated the phthalate ban for rattles and tethers into the Consumer Safety Specification for Toy Safety ASTM F963.

The EU took a more precautionary approach on the subject despite objections from the European Council of Plasticizers and Intermediates (ECPI) which accused the European Commission of “putting politics before science.” In 1999 the European Parliament imposed a temporary three-month ban on the use of three phthalate plasticizers — DEHP, DBP, and BBP — in all children’s toys and child-care items. It also banned the use of three others — DINP, DIDP, and DNOP — in toys and child-care items that children can put in their mouths. The ban was repeatedly renewed and officially came into effect in 2007.

“There is an important point to remember regarding the EU phthalate bans,” says Louis R. Cappucci, vice president of the Teknor Apex’s Vinyl Div., Pawtucket R.I. “The EU scientific community conducted an extensive review of the toxicology and found that no ban was necessary — phthalates were safe to use in the toy market. The phthalate ban was imposed by the Legislature before the scientific review was complete.” Teknor Apex is not a major supplier of vinyl to the toy industry, but it does supply plasticizers to a range of industries that could be affected if the “blanket” ban on PVC use by retailers comes to fruition.

Based on EU and other U.S. scientific reviews (including the CPSC review of phthalates), Cappucci says Teknor has no plans to phase out the banned phthalates. “Teknor has plasticizer alternatives to phthalates for many applications, but few customers have been willing to pay the increased costs of the alternatives. Basically, they get less performance for more money,”says Cappucci. “All the products we produce for the medical and many other markets meet the requirements set by the FDA, CPSC, NSF, UL, and other organizations that develop standards for the industries we serve.”

The European Council of Vinyl Manufacturers (ECVM) also expressed concern that legislation in Brussels misused the precautionary principle. “DINP is by far the most common phthalate used in the production of toys,” says ECVM. “There are alternatives to phthalates which could be used but they have not been tested or researched nearly as thoroughly. It is therefore very concerning that the EU is forcing substitution when less is known about the alternatives than about the existing substances.”

One phthalate-free plasticizer is Hexamoll DINCH from BASF Aktiengesellschaft in Germany. The PVC plasticizer was developed specifically for use in sensitive applications including toys and medical devices. Thanks to the 4th Amendment of Directive 2002/72/EC, which regulates additives and monomers in contact with food, BASF expects it to see more use in food-contact applications such as packing films, tubes, and seals.

PVC debate to date
The PVC battle has raged for the past decade. One problem: Consumers and activists want categorical assurances that chemicals used in toys and child-care articles are absolutely safe. But scientists can only state that there’s no evidence to suggest danger. This answer sounds weak in comparison to salacious assertions from the media savvy anti-PVC camp whose ultimate goal is the complete elimination of PVC use, period. A PVC ban would include everything from Tygon tubing, garden hoses, shower curtains, wire and cable insulation, vinyl siding and miniblinds, and pipes, to toys and medical devices. Some environmentalists feel that PVC and its monomer polyvinyl chloride are so toxic that the only way to ensure human safety is to shut down every PVC plant. Some have even proposed digging a giant pit that’s triple lined with protective films and burying every shred of PVC that’s ever been produced.

Opponents, including TIA, have decried many anti-PVC media reports as incendiary and scientifically irresponsible. For example, Dr. Shanna Swan, director of the Center for Reproductive Epidemiology at the University of Rochester School of Medicine and Dentistry, first made headlines in 2005 when her report Decrease in anogenital distance among male infants with prenatal phthalate exposure hit the airwaves. “The importance of what the study attempted to establish, and what it did not, was quickly lost in media coverage,” says Rebecca Goldin, George Mason University associate professor and member of the nonprofit, nonpartisan Statistical Assessment Service organization. The STATS goal is to correct scientific misinformation in the media resulting from bad science, politics, or a simple lack of information or knowledge; and to act as a resource on major scientific issues and controversies.

Swan’s report resulted in headlines with scary titles including “Study links plastics to small genitals” (Fox News) and “Chemical may harm sex organs of prenatal boys” (MSNBC). “The headlines misrepresent the issue and give the public the impression that children are at risk when the body of research is far from conclusive,” says Goldin.

Goldin contends the media has in part been led astray. “Swan has publicly taken the position that the correlation between phthalate exposure in utero and anogenital index (the distance between the anus and scrotum) proves that phthalates are causing reproductive harm, even though the study found neither actual genital defects nor fertility problems.” Industry groups claim the study is without merit because it is impossible to tell whether the “smaller anogenital index” found in phthalate-exposed boys is outside the normal range.

The National Institute of Health reported DINP did not cause reproductive health problems for rodents. DINP, however, has not made it through scientific scrutiny unscathed. One animal study found that DINP caused an increased incidence of liver tumors (carcinomas and adenomas) in rats and mice. But the CPSC says there is uncertainty about the actual mechanism by which compounds such as DINP contribute to cancer in animals and whether this mechanism applies to humans. The NIH and other health organizations, therefore, supported studies to evaluate the risks DINP and other phthalates pose to children that mouth their toys. The CPSC, for example, conducted a three-year review and concluded, “There may be a DINP risk for children who routinely mouth DINP-plasticized toys for 75 min/day or more. But for the majority of children, the exposure to DINP from DINP-containing toys would be expected to pose a minimal to nonexistent risk of injury.”

The EU’s risk assessment for DINP and DIDP also concluded that toys and baby products containing DINP were unlikely to pose a risk for infants and newborns following inhalation, skin contact, and ingestion. But the report also provided a “Strategy for Limiting the Risk for Consumers.” It basically suggests the use of phthalates DINP, DIDP, and DNOP only in articles which cannot be placed in the mouth of children under three years and restricts the use of DEHP, DBP, and BBP in toys and child-care articles.

Phthalates just the tip of the iceberg?
This January, the European Commission announced it wants to strengthen EU-rules, especially those relating to the use of chemical substances in toys. Its aim is to modernize a 20-year-old Toys Directive with higher safety requirements. It will also make manufacturers and importers more responsible for the marketing of toys and boost the market surveillance obligations of EU members.

Likewise, in the wake of numerous toy recalls last year, two bills are working their way through the U.S. Congress with the blessing of the toy industry. They’ll make toy testing mandatory, further restrict lead in toys, provide for a mandatory toy safety certification program, put cautionary language in toy ads, and give toys traceability markings. TIA also supports provisions of the House and Senate bills that would the CPSC additional resources, technical staff, and authority. But TIA along with the ACC are concerned about the Senate bill (S. 2663, the Consumer Product Safety Commission Act): An amendment by U.S. Senator Dianne Feinstein (DCalif.) would impose a nationwide ban on phthalates in children’s toys and products.

The fallout from the EU and impending U.S. toy legislation, coupled with ambiguously worded “anti-PVC use” mandates from major retailers, could have devastating consequences for unprepared OEMs. Despite what some anti-PVC activists suggest, it could be tough to find alternative materials for soft PVCs that stand up to such hazardous substance regulations as Reach (Registration, Evaluation, Authorisation, and Restriction of Chemical substances). Reach, another EU Directive, has a wide scope. It covers all substances whether manufactured, imported, used as intermediates or placed on the market, either on their own, in preparations, or in articles. Polymers currently need not be registered under Reach because they are usually not considered hazardous. But in certain circumstances monomers in polymers must be registered. The EU also reserves the right to impose future restrictions on other polymers if needed.

Alternatives to PVC?
“Soft PVC has unique characteristics in toys which may be hard to achieve with alternative polymers,” says Allen Blakey director public affairs of the The Vinyl Institute, Arlington, Va. “It holds doll hair better than other plastics, is easy to pigment with bright primary colors, and can be rotomolded into delicate features such as tiny ears and noses.” Many polymers, including vinyl, need plasticizers and additives that serve as heat and light stabilizers, cautions Blakey. These additives and plasticizers, and other types of polymers have likely not gone through the same rigorous safety and mouthing tests as that seen by the phthalates used in PVC.

Polycarbonate (PC), for example, has recently come into environmental crosshairs. Although PC is not an alternative to soft PVC, it goes in many hard baby-care items including bottles and sippy cups. The recent publication Baby’s Toxic Bottle reports that Bisphenol A (BPA), a building block of PC, has been found to leach out of six major brands of baby bottles sold in the U.S. and Canada. The report states that animal studies have shown that BPA damages the reproductive, neurological, and immune systems during critical stages of development, such as infancy and in the womb.

Designers looking to replace PVCs may want to note that the BPA monomer is also used in polyesters, polysulfones, and polyacrylate resins. It also serves as an antioxidant in plasticizers and goes into some flame retardants. For another view, take a cautionary look at what Greenpeace had to say in its 1999 report A Review of the Availability of Plastic Substitutes for Soft PVC in Toys. There the organization lists what it considers noneco-friendly polymers.

The author, Joel Tickner, ranked numerous plastics in a worst (PVC) to best (bio-based polymers) hierarchy. He also contends that all synthetic plastics including high-density polyethylene (HDPE), polypropylene (PP), polystyrene (PS), PVC, nylons, acrylonitrilebutadiene styrene (ABS), acetal resins (POM), acrylics (PMMA), PC, and polyurethane (PU) all have environmental problems from production to disposal.

Tickner says there are some petroleum-based plastics that are eco-friendly and biodegradable. But they cannot be considered an environmentally safe, sustainable replacement for PVC in the long run. “The future,” he says, “lies in bio-based plastics from plant materials (starch, cellulose), polylactic acid (PLA), or bacteria (bacteria are fed sugars and create the polymer as a waste product).”

One problem: The bio-based PLA polymer from Nature- Works LLC, Minnetonka, Minn., for example, isn’t currently an ideal candidate to replace soft PVC in toys such as a doll heads. However, it could be used in more rigid structural parts.

The physical and rheological properties of the Nature- Works biopolymer have been exploited for rigid thin-gauge packaging applications, says NatureWorks’ Salvador Ortega, marketing manager. Ortega says compounders are combining NatureWorks biopolymer with conventional thermoplastics to develop first-generation materials more durable than the company’s current packaging grades. Some of these have gone into electronic applications. “But currently,” says Ortega, “we don’t have a toy-specific grade that would compete physically or economically with PVC.” The good news, says Jeff Smith, NatureWorks director, products and application development, is that the company now works with compounding manufacturers that are blending NatureWorks biopolymer with other thermoplastics to produce grades that are softer and more durable, and that could be injection molded for toys.

One of the first things the toy industry needs to define, says Ortega, is the definition of durable. Right now, makers of PVC alternative materials don’t know whether they are shooting for a service life of 5, 10, or 20 years, he says. Additionally, a 100% biopolymer product would, like some other plastics, not stand up well to a combination of high temperature (140°F) and high (90%) relative humidity over an extended period. But, says Smith, “Injection molders have adjusted molding processes to crystallize our biopolymer in the mold and thus boost heat resistance for items such as coffee cups.

NatureWorks biopolymer is food-contact compliant, but cautions Smith, that approval is no longer valid if it is compounded with another polymer or has been pigmented or filled with other additives. In that case a designer must go through FDA compliance again.

From a cost standpoint, says Smith, “Our NatureWorks biopolymer may not be as competitive as conventional materials used in toys. And our first-generation materials may need slower cycle times. Nevertheless, NatureWorks feels its biopolymer (PLA) will eventually be a strong candidate to replace commodity resins used for durable goods. And compared to emerging biopolymers just entering the market, “We consider ourselves very competitive today,” says Smith.

One company, I Play, Asheville, N.C., is working on several PLA-based products and is not afraid to spend a little more on a material that matches the company’s mission statement. According to Becky Cannon, I Play president and founder, “I Play has been a champion for safe, eco-friendly, responsible products. My manufacturing team spends as much time making sure our products are safe as we do making them look cute.” To this end, the company follows the EU legislation closely, selling only PVC-free baby bibs , raingear, and bath toys. And with the BPA concerns, I Play also has BPAfree Aqua bottles along with a line of organic cotton clothing. I Play Sales Manager Tony Ford says companies that make toys and childcare products must stay ahead of the “toxic curve.” “Gen Y parents are socially connected, information savvy, and not at all reliant on traditional mass mediums or communication methods,” he says.

Gen Ys were born between 1980 and 1995 and “grew up being environmentally conscious and learning to gather and share information collaboratively to address those concerns, says Ford. “They know how to discover every bit of information, health testing, and scientific data about the products they are considering. Gen Y is used to assimilating rapidly changing information and altering their decisions and purchasing based on it.”

It’s likely that most toymakers will eye their use of plastics warily to stay ahead of the toxic curve, Ford maintains. “You won’t be able to fool Gen Ys. They will want to know and be able to know everything about your product and what it means for them and their families.”

Make Contact
BASF Aktiengesellschaft,
basf.com

Center for Health, Environment, and Justice,
(703) 237-2249, chej.org

European Council of Vinyl Manufacturers,
www.ecvm.org

Green Toys Inc.,
(415) 839-9971, greentoys.com

I Play,
(828) 254-9236, iplaybabywear.com

NatureWorks LLC,
(800) 664-6436, www.natureworksllc.com

Teknor Apex,
(800) 556-3864, teknorapex.com

Toy Industry Association,
(212) 675-1141, toyassociation.org

Statistical Assessment Service,
(202) 223-3193, stats.org

Vinyl Institute,
(703) 741 5670, vinylinstitute.com

 

The EU Commission drafted the Guidance Document on the interpretation of the concept “which can be placed in the mouth” as laid down in the Annex to the 22nd amendment of Council Directive 76/769/ EEC to help ensure a common understanding of the PVC phthalate restrictions for toys and child-care items. Handheld toys are more likely to be placed into the mouth. But other so-called child-care items can have problematic components. For example, it is currently impossible for the average consumer to tell what parts of a doorway bouncy chair, for example, might be PVC. It was easy, however, for this reporter to observe that most of the entertainment items on the swing tray were often either mouthed or licked by my niece and nephew. Items such as these, therefore, may ultimately be subject to the EU Directive.

Green Toys Inc., San Francisco, recently launched a line of line of toys made from recycled plastic milk containers. The company ran thirdparty independent laboratory tests to ensure its toys contain no traceable amounts of phthalates or BPA. Additionally, the toys meet FDA requirements for food contact and were designed without external coatings, eliminating fears of lead paint.

I Play will soon launch a line of PVC-free play teacups and dining ware made from NatureWorks LLC’s PLA biopolymer. In addition to toys, I Play’s PVC-free products include rain boots, sunglasses, bibs, and rattles as well as organic cotton children’s clothing and BPA-free Aqua bottles.